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FDA 510(k)

SCS CLOSED SCREW

K-Number: K003733 · 2001-05-29

ApplicantOrtho Tec, LLC
Decision Date2001-05-29
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCS CLOSED SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K003733. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCS CLOSED SCREW?

SCS CLOSED SCREW is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Ortho Tec, LLC. The 510(k) number is K003733.

When did SCS CLOSED SCREW receive FDA 510(k) clearance?

SCS CLOSED SCREW received FDA 510(k) clearance on 2001-05-29, under 510(k) number K003733.

Who is the listed applicant for SCS CLOSED SCREW?

The FDA 510(k) record lists Ortho Tec, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCS CLOSED SCREW?

The FDA product code for SCS CLOSED SCREW is MNH. This falls under the ENT category.

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Other records listing Ortho Tec, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MNH)

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K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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